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www.fdanews.com/articles/71276-fda-approves-barr-mylan-and-ivax-s-anagrelide-hcl-capsules

FDA Approves Barr, Mylan and Ivax's Anagrelide HCl Capsules

April 19, 2005

The FDA has given final approval to Barr Laboratories, Mylan Laboratories and Ivax Pharmaceuticals for generic versions of Shire Pharmaceuticals' Agrylin (anagrelide HCl) capsules in 0.5- and 1-mg doses.

The drug is indicated to treat patients with thrombocythemia, a condition in which there is an excess of platelets in the blood, resulting in bleeding, blood clots, enlarged spleen or stroke. Anagrelide HCl capsules had sales of $107 million for the 12 months ended Feb. 28, according to IMS Health.